Events

Recall of Orotracheal Lighted Stylet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Colorado Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49140
  • Event Risk Class
    Class 2
  • Event Number
    Z-2455-2008
  • Event Initiated Date
    2008-08-11
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73206
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tracheal tube stylet - Product Code BSR
  • Reason
    Light protector may detach from lighted stylet during intubation.
  • Action
    Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.

Device

Orotracheal Lighted Stylet
  • Model / Serial
    Lot numbers: X144, X172, X217, X273, X299, X300, X307, X333, X350, 052A, 081A, 093A, 166A, 271A, 319A, 349A, 033D, 101D, 116D, 164D, 219D, 233D, 291D, 346D, 004F, 058F, 063F, 197F.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.
  • Product Description
    Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • Manufacturer Address
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA